24 May 2016

How are European laws, directives and standards connected?

Find out all you need to know about the specifications within the European Union (EU) for the engineering industry.

Within the European Union (EU), laws, regulations and provisions for the engineering industry are being increasingly harmonised. As a result, each country no longer has its own specifications. Instead there are uniform regulations in Europe in more and more cases.

Relationships worth knowing about

Initially, the EU formulates general safety objectives via directives. These safety objectives need to be specified more precisely; the actual provision is made via standards.

EU directives generally deal with specific issues. They only come into effect through the agreements of individual countries within the EU, who incorporate these directives into their domestic law. So although the titles of these documents describe them almost harmlessly as directives, in practice they have legal status within the EU.

When do standards have legal relevance?

Standards alone still do not have direct legal relevance until they are published in the Official Journal of the EU or are referenced in domestic laws and provisions. These are the publications by which a standard can acquire “presumption of conformity”. This means that a manufacturer can assume he has met the requirements of the corresponding directive provided he has complied with the specifications in the standard. In a formal, legal context this is called a reversal of the burden of proof. Where the manufacturer applies a harmonised standard, if there is any doubt, misconduct will need to be proven.

Standards that were not published in the Official Journal are not considered harmonised. The presumption of conformity therefore does not apply for them.

If no standards exist yet - as is the case in innovative industries in particular - a manufacturer must then demonstrate independently that he has taken the necessary care to comply with the safety objectives of the relevant directives.